Course No 15437
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Pfizer, United Kingdom
Janssen Pharmaceutica, Belgium
This pre-Conference Session provides an interpretation of the GMP principles for the manufacture of APIs against the backdrop of the ICH Q7 Questions and Answers Document.
You will get to know:
Which aspects of ICH Q7 have to be re-considered
What are the practical consequences of the ICH Q7 Q&A document
What has tobe taken into account when preparing for a GMP inspection
Furthermore you will have the opportunity to reach clarification on ambiguous issues by bringing your questions concerning ICH Q7 up for discussion.
Create your own Workshop:
You will be asked to choose 5 Questions/Answers out of the Q&A document you would like to be discussed during the workshop session.
For this purpose you will receive a questionnaire after having registered for this pre-Conference Session.
Those Questions/Answers of the Q&A Document chosen by the participants as being of main interest will be discussed during the afternoon workshop session.
This pre-conference session ideally complements the following 19th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients.
Since its successful implementation in the regulatory framework by most authorities around the world experience has been gained with the ICH Q7 Guideline on „Good Manufacturing Practice for Active Pharmaceutical Ingredients“. Meanwhile it turned out that ambiguities related to the interpretation of some sections in ICH Q7 may lead to misconceptions. Furthermore the principles outlined in the ICH Guidelines Q8 – Q11, in particular the life cycle approach and some technical issues related to API manufacturing procedures, need also to be considered in order to achieve a comprehensive implementation of GMP for APIs.
The ICH Q7 Questions & Answers Document which reached Step 4 of the ICH process in June 2015 intends to remove these ambiguities and to contribute as well to harmonization of GMP inspections of both small molecules and biotech APIs.
This pre-conference session is designed for all persons involved in the manufacture of APIs especially for persons from production, quality control, quality assurance and control, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry and GMP inspectorates.
The ICH Q7 Questions and Answers Document – an overview
Intention of the Q&A Document
Some highlights from the Q&A Document
Advantages to Industry of the Q&A document
Interpretation of the ICH Q7 Guide: APIC’s „How to do Document“
Information on APIC
Purpose of the “How to do” Document
Content and highlights
Interrelationship to the ICH Q7 Q&A document
Worked examples from the ICH Q7 Q & A Document
Important Questions/Answers out of the ICH Q7 Q&A Document
The Q&As of main interest chosen by the participants of the pre-Conference Session will be discussed –